Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

Collaboration for Antepartum Risk Evaluation (CARE)

10. Dezember 2020 aktualisiert von: Julia Phillippi, Vanderbilt University

Interprofessional Perinatal Consults to Improve Communication Quality, Satisfaction, and Team Cohesion: A Randomized Trial of the Collaboration for Antepartum Risk Evaluation (CARE) Model

Perinatal outcomes in the US rank behind most other developed countries even though women in the US utilize more maternity services. Current approaches to consultation and collaboration among perinatal care providers, including nurse-midwives, obstetricians, and perinatologists, fragment care resulting in communication errors and maternal dissatisfaction. The CARE study will test an innovative interdisciplinary consult visit to improve communication, teamwork, maternal satisfaction, and perinatal outcomes.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Perinatal outcomes in the United States rank below many other developed countries. National organizations, such as the American College of Obstetricians and Gynecologists, have called for women to utilize the level and provider of maternity services that meet their personal and medical needs. This leveled approach to care requires consultation and collaboration among providers to ensure women receive appropriate services. While national and international organizations have called for team-based maternity care, current models can fragment services, increasing the risk of communication errors. Women can feel disenfranchised by models that do not meet their needs and opt out of beneficial services altogether.

Currently, there is not evidence on effective interdisciplinary models of maternity care. The Collaboration for Antepartum Risk Evaluation (CARE) study will use a randomized design to systematically test the effect of interdisciplinary consults on women and providers. The two aims of the study are: (1) evaluate the effect of collaborative vs individual consults on participant outcomes including communication quality (using the Communication Assessment Tool, team version), maternal satisfaction (using a modified Satisfaction with Prenatal Care measure), semi-structured interviews, adherence to the developed plan of care, and perinatal outcomes; (2) evaluate the effect of the CARE clinic on providers using the Communication Assessment Tool- team version, the Agency for Healthcare Research and Quality (AHRQ) Team Strategies and Tools to Enhance Performance and Patient Safety (TeamSTEPPS) questionnaire, and semi-structured interviews.

The CARE study will provide valuable information on effective models for patient-centered maternity care. The AHRQ K08 will allow Dr. Philippi to implement the CARE study and facilitate her growth into a national leader in midwifery and health services research.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

182

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Tennessee
      • Nashville, Tennessee, Vereinigte Staaten, 37240
        • Vanderbilt School of Nursing

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Weiblich

Beschreibung

Inclusion Criteria:

  • Adult pregnant women receiving prenatal care at the VUSN Nurse-Midwifery Faculty Practice.
  • Gestational age of pregnancy 4-40 weeks
  • Needs a consultation with perinatologist for one of the following reasons:

Prior pregnancy with congenital abnormality History of fetal demise >20 weeks History of preterm labor in previous pregnancy Current maternal drug or alcohol abuse Controlled maternal condition (e.g. thyroid disorder) Mild abnormality of fetus or placenta on ultrasound Idiopathic thrombocytopenia in pregnancy

  • Can attend the collaborative care clinic

Exclusion Criteria:

  • Unable to give consent for research participation - including age < 18 or impaired mental function
  • Urgent medical condition requiring immediate assessment including: ectopic pregnancy or vaginal bleeding
  • Medical conditions outside of scope of VUSN midwifery guidelines including:

Chronic maternal conditions requiring specialist involvement including: HIV, epilepsy, uncontrolled asthma, and liver, renal, cardiac disease.

Multiple gestation > 2 previous cesarean births Rh isoimmunization Incompetent cervix Major fetal or placenta abnormalities

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Versorgungsforschung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Collaborative Care
Intervention Group: Women (n=118) will be seen one time, simultaneously by a Vanderbilt University Medical Center (VUMC) perinatologist and a Vanderbilt University School of Nursing (VUSN) nurse-midwife (the CARE visit). During the CARE visit, the nurse-midwife and perinatologist will complete the CARE checklist The checklist will be signed by the woman and providers and scanned into the medical record. Following the CARE visit, women will return to midwifery care or be referred to perinatology depending on their needs, remaining in the study. Women returning to the midwifery practice will see a primary midwife for the remainder of care.
Verhalten: Collaborative Care
Intervention Group: Women (n=118) will be seen one time, simultaneously by a VUMC perinatologist and a VUSN nurse-midwife (the CARE visit). During the CARE visit, the nurse-midwife and perinatologist will complete the CARE checklist The checklist will be signed by the woman and providers and scanned into the medical record. Following the CARE visit, women will return to midwifery care or be referred to perinatology depending on their needs, remaining in the study. Women returning to the midwifery practice will see a primary midwife for the remainder of care.
Aktiver Komparator: Comparison Care- Usual Care + primary midwife
Comparison Group: Usual care enhanced with primary midwife. Women in the comparison group (n=118) will receive the standard individual consult visit with a perinatologist and then, if they return to midwifery care, have one consistent midwife (primary midwife) for the majority of remaining prenatal care.
Verhalten: Comparison Care- Usual Care + primary midwife
Comparison Group: Usual care enhanced with primary midwife. Women in the comparison group (n=118) will receive the standard individual consult visit with a perinatologist and then, if they return to midwifery care, have one consistent midwife (primary midwife) for the majority of remaining prenatal care.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Communication Assessment Tool (CAT)-Team survey
Zeitfenster: 2 weeks after intervention/comparison visit
The CAT, developed by Makoul et al., assesses views of provider communication via 14 Likert responses ranging from 1= 'poor' to 5= 'excellent.
2 weeks after intervention/comparison visit
Satisfaction with Prenatal Care (SPC) scale
Zeitfenster: 2 weeks after intervention/comparison visit
The SPC scale assesses patient satisfaction with prenatal care
2 weeks after intervention/comparison visit
Communication Assessment Tool (CAT)-Team survey - following birth
Zeitfenster: Within 2 weeks after patient gives birth
The CAT, developed by Makoul et al., assesses views of provider communication via 14 Likert responses ranging from 1= 'poor' to 5= 'excellent.
Within 2 weeks after patient gives birth
Satisfaction with Prenatal Care (SPC) scale - following birth
Zeitfenster: Within 2 weeks after patient gives birth
The SPC scale assesses patient satisfaction with prenatal care
Within 2 weeks after patient gives birth

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Smoking at 1st prenatal visit
Zeitfenster: 1 week after the patient gives birth
1 week after the patient gives birth
For smokers, number of cigarettes per day
Zeitfenster: 1 week after the patient gives birth
Number of cigarettes per day
1 week after the patient gives birth
Location of birth
Zeitfenster: 1 week after patient gives birth
Location where the mother gave birth - Vanderbilt / Other hospital, Birth center, Home, En Route
1 week after patient gives birth
Provider at admission to labor and delivery
Zeitfenster: 1 week after patient gives birth
Medical care provider at the time of admission in labor
1 week after patient gives birth
Patient & provider adherence to checklist plan
Zeitfenster: 1 week after patient gives birth
Congruence between the anticipated plan of care at the time of the intervention/comparison visit and what occurred at the time of birth
1 week after patient gives birth
Gestational age at birth
Zeitfenster: 1 week after patient gives birth
the gestational age of the baby at the time of birth - in weeks+days
1 week after patient gives birth
Infant birth weight
Zeitfenster: 1 week after patient gives birth
Infant birth weight in grams as collected within 4 hours of birth
1 week after patient gives birth
Mode of birth
Zeitfenster: 1 week after patient gives birth
Number of women giving birth via 1 of 4 methods: vaginal/assisted vaginal/cesarean after labor/planned cesarean
1 week after patient gives birth
Trial of labor after cesarean
Zeitfenster: 1 week after the mother gives birth
Whether the woman was attempting a trial of labor after a previous cesarean birth
1 week after the mother gives birth
Vaginal birth after cesarean
Zeitfenster: 1 week after patient gives birth
Whether the woman gave birth vaginally with this infant after she had a previous cesarean birth.
1 week after patient gives birth
Complications at birth
Zeitfenster: 1 week after patient gives birth
The presence of any adverse outcomes during pregnancy, birth, postpartum, including details
1 week after patient gives birth
Breastfeeding at birth
Zeitfenster: 1 week after patient gives birth
Breastmilk feeding of the infant at the time of birth
1 week after patient gives birth
Breastfeeding at discharge
Zeitfenster: 1 week after patient gives birth
Breastmilk feeding of the infant at the time of discharge.
1 week after patient gives birth
Hospital stay postpartum
Zeitfenster: 1 week after patient gives birth
Lengths of postpartum hospital stay in calendar days
1 week after patient gives birth
Generalized Anxiety Disorder 7-item scale (GAD-7)
Zeitfenster: 2 weeks after intervention/comparison visit
Measure of anxiety level. Scale can range from 0-21 with higher scores representing greater anxiety.
2 weeks after intervention/comparison visit
Generalized Anxiety Disorder 7-item scale (GAD-7)
Zeitfenster: Within 2 weeks after patient gives birth
Measure of anxiety level. Scale can range from 0-21 with higher scores representing greater anxiety.
Within 2 weeks after patient gives birth

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Vanderbilt University

Ermittler

  • Hauptermittler: Julia Phillippi, PhD, Vanderbilt School of Nursing

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Juli 2016

Primärer Abschluss (Tatsächlich)

1. Oktober 2020

Studienabschluss (Tatsächlich)

1. Oktober 2020

Studienanmeldedaten

Zuerst eingereicht

18. Mai 2016

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

25. Mai 2016

Zuerst gepostet (Schätzen)

30. Mai 2016

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

14. Dezember 2020

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

10. Dezember 2020

Zuletzt verifiziert

1. Dezember 2020

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • 160523

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

Will share deindentified data after submission of the Data Use Agreement

IPD-Sharing-Zeitrahmen

Will share deindentified data after submission of the Data Use Agreement

IPD-Sharing-Zugriffskriterien

To be determined

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT
  • ICF

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Klinische Studien zur Collaborative Care

Suchen Sie nach ähnlichen Studien

Sponsoren und Mitarbeiter

Krankheiten

Drogeninterventionen

CROs by country

CROs in Saint Lucia

Bedingungen

Seltene Krankheiten

Drogeninterventionen

Nahrungsergänzungsmittel

Sponsor / Mitarbeiter

Standorte

3
Abonnieren